BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL

    MDR report key: 8659234 · Received May 31, 2019

    Report

    Report Number
    1911916-2019-00545
    Event Type
    Malfunction
    Date Received
    May 31, 2019
    Date of Event
    September 25, 2018
    Report Date
    May 15, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    30382903065470
    PMA / PMN Number
    K161552
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: NO SAMPLES WERE RECEIVED. NO PHOTOS WERE PROVIDED. INVESTIGATION CONCLUSION: THIS IS THE 1ST COMPLAINT FOR LOT # 8141931 FOR THIS TYPE OF DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH. ROOT CAUSE DESCRIPTION: ROOT CAUSE CAN¿T BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL EXPERIENCED LEAKAGE PAST STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 306547, BATCH NO. 8141931. (11 OF 12). "THE PLUNGER ON THE SYRINGE IS NOT COMPLETELY LEVELED AND SUCTIONED SO BLOOD HAS BEEN PUSHING THE END OF THE SYRINGE OUT CAUSING BLOOD LEAKS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453466 SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 8141931 30382903065470

    Patients

    Seq Age Sex Outcome Treatment
    1 Other